Clinical Laboratory / CLIA
42 CFR Part 493. CAP. COLA. One platform, every compliance control.
Built for CLIA-certified labs running moderate and high complexity testing. Every QC review, proficiency testing cycle, personnel qualification, and corrective action managed under 42 CFR 493 governance with immutable documentation.
Built for Clinical Laboratory / CLIA
Every capability is purpose-built for your compliance environment — not adapted from a generic platform.
CLIA Self-Audit
AI-powered self-audit scores your lab against 42 CFR 493 subparts — from QC (§493.1256) to personnel (§493.1405) to proficiency testing (§493.801). Downloadable audit report for your CAP/COLA inspector.
QC Management
Westgard rule monitoring, Levey-Jennings charts, and QC failure alerts. Every out-of-control event linked to a corrective action and re-verification before patient result release.
Proficiency Testing Tracking
Log PT results, track enrollments, and auto-trigger CAPAs on PT failures. AILS documents the investigation and corrective action required under §493.841.
Personnel Qualifications
Track CLIA-required qualifications, initial competency assessments, and ongoing competency evaluations. Hard block on testing procedures when competency is overdue.
Chain of Custody + Result Reporting
Full specimen lifecycle from intake to result. Immutable COAs for final patient reports — SHA-256 locked, no post-issue edits by anyone.
SOPs + Training Gates
CLIA-compliant procedure manual with mandatory training sign-off. API-enforced training gates — expired competency blocks access, not warns.
Purpose-built agents for Clinical Laboratory / CLIA
Each agent operates on your live lab data, scoped to one specific job. Not a generic assistant.
CLIA Self-Audit Agent
Assesses your lab against all applicable 42 CFR 493 subparts. Generates a scored readiness report with finding severity classifications and recommended corrective actions.
COA AI Quality Checker
Scans every issued result report against your method specifications. Flags outliers, reference range deviations, and delta check failures before results reach clinicians.
SOP AI Generator
Drafts CLIA-compliant procedure sections referencing 42 CFR 493 requirements and CLSI guidelines applicable to your test menu.
Module key: clia — enabled at tenant provisioning
One platform. Your vertical. Ready today.
AILS is already live in Clinical Laboratory environments. Every workflow, every compliance framework, every AI agent — deployed and tested. Zero architectural changes needed to go live.